MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for CODEMASTER XL+ M1722A manufactured by Philips Medical Systems.
[144947717]
The device was evaluated by the customer and then the service call was cancelled. The customer does not intend the repair the device. Philips is unable to be determined what caused the issue.
Patient Sequence No: 1, Text Type: N, H10
[144947718]
It was reported to philips that the device had a electrode plates fault. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2019-03462 |
| MDR Report Key | 8604801 |
| Date Received | 2019-05-13 |
| Date of Report | 2018-12-25 |
| Date Mfgr Received | 2018-12-25 |
| Date Added to Maude | 2019-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. BETHANY GLYNN |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CODEMASTER XL+ |
| Generic Name | DEFIB/MONITOR |
| Product Code | LDD |
| Date Received | 2019-05-13 |
| Model Number | M1722A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-13 |